NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)
- Conditions
- Mild Cognitive ImpairmentParkinson DiseaseMild DementiaLewy Body Disease
- Interventions
- Drug: Placebo Oral Capsule
- Registration Number
- NCT04148391
- Lead Sponsor
- Aptinyx
- Brief Summary
A Study to Evaluate NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Associated With Parkinson's Disease or Prodromal or Manifest Lewy Body Dementia
- Detailed Description
The study will be a 16 to 18-week study, including a 2 to 4-week screening period, followed by a 12-week double-blind, randomized, placebo-controlled treatment Period, and a 2-week follow-up period. Subjects eligible for the study will be randomized to receive either NYX-458 or placebo.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 99
- Informed Consent
- Diagnosis of Parkinson's disease and mild cognitive impairment or mild dementia OR diagnosis of mild cognitive impairment or mild dementia with Lewy bodies
- Presence of subjective cognitive complaints by the patient
- Verifiable impairment, as defined a CGI-S (Clinical Global Impression-Severity) score of at least 3 (mildly ill).
- Score on the MoCA (Montreal Cognitive Assessment) between 15 and 25, inclusive.
- Stable anti-parkinsonian regimen (if applicable)
- Has a study partner who can accompany the subject at specified study visits
- Clinically meaningful motor complications
- Current use of medications with primarily central nervous system activities
- Other clinically significant medical histories that may interfere with completing the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral Capsule Matching placebo Capsules NYX-458 30 mg NYX-458 Single oral dose taken daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Change from baseline in vital signs, clinical laboratory values, and electrocardiogram results Subjects will be followed up to 14 days post-dose Vital signs, clinical laboratory values, and electrocardiogram results
Change from baseline dissociative effects, psychosis, and hallucinatory symptoms as measured by the Neuropsychiatric Inventory (NPI-12) Subjects will be followed up to 14 days post-dose Neuropsychiatric Inventory (NPI-12) - NPI-12 assesses 12 behavioral domains common in dementia. Higher scores indicate more severe illness.
Change from baseline in physical examination Subjects will be followed up to 14 days post-dose Physical examination
Rates of adverse events and serious adverse events Subjects will be followed up to 14 days post-dose Adverse events and serious adverse events
Rates of early termination due to adverse events Subjects will be followed up to 14 days post-dose Early termination due to adverse events
Change from baseline in suicidal ideation and behavior as measured by the Sheehan Suicidality Tracking Scale (S-STS) Subjects will be followed up to 14 days post-dose Sheehan Suicidality Tracking Scale (S-STS) is a 16-item scale that assesses the seriousness of suicidality phenomena on a likert-type scale (0 to 4) ranging from 0 = not at all to 4 = extremely
Change from baseline in motor complications as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 4 Subjects will be followed up to 14 days post-dose Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 4 includes 6 items assessing motor complications, higher scores indicate more serious illness.
Change in total score of the Sheehan Suicidality Tracking Scale (S-STS) Subjects will be followed up to 14 days post-dose Sheehan Suicidality Tracking Scale (S-STS) is a 16-item scale that assesses the seriousness of suicidality phenomena on a likert-type scale (0 to 4) ranging from 0 = not at all to 4 = extremely
- Secondary Outcome Measures
Name Time Method Change from baseline in the One Back test Week 12 The One Back test is a measure of working memory
Change from baseline in the Two Back test Week 12 The Two Back test is a measure of working memory
Change from baseline in the Groton Maze Learning Test Week 12 The Groton Maze Learning test is a measure of problem solving and reasoning
Change from baseline in the Identification Test Week 12 The Identification test is a measure of visual attention
Change from baseline in the International Shopping List Test Week 12 The International Shopping List test is a measure of verbal learning
Change from baseline on Continuous Paired Associate Learning Test Week 12 The Continuous Paired Associate Learning test is a measure of visual associate memory
Trial Locations
- Locations (1)
Aptinyx Clinical Site
🇺🇸Spokane, Washington, United States
Aptinyx Clinical Site🇺🇸Spokane, Washington, United States